The following data is part of a premarket notification filed by Life Spine with the FDA for Plateau Spacer System.
| Device ID | K080411 |
| 510k Number | K080411 |
| Device Name: | PLATEAU SPACER SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169 |
| Contact | Rebecca M Brooks |
| Correspondent | Rebecca M Brooks LIFE SPINE 2401 W. HASSELL RD. SUITE 1535 Hoffman Estates, IL 60169 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-15 |
| Decision Date | 2008-05-15 |
| Summary: | summary |